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What is informed consent?

Informed consent is a written contract outlining your commitment to participate in a clinical research study. Once you have been fully informed and educated about the nature of the clinical trial, you or your representative will sign this agreement confirming your consent. The U.S. FDA necessitates that each participant in a clinical trial provide written informed consent, dictating that you understand and agree to the potential risks.

In terms of informed consent, you should only sign the agreement if you have had ample time to consider the risks, benefits and whether you wish to participate. An informed consent contract cannot include any language that frees the research physician, drug manufacturer or medical facility conducting the research from the normal standard of care for your well-being.

Be sure to ask any questions and voice any concerns you may have before providing informed consent. Being fully educated and informed will prepare you to make this type of important decision. Informed consent is more than just signing papers. It is your right and responsibility as a participant in any clinical trial to provide your informed consent to participate.

The Most Common Questions:

 FAQ’s on Clinical Trials:

Understand Your Rights: